Olverembatinib

ROCKVILLE, Md. and SUZHOU, China, Nov. 28, 2024 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet medical needs primarily for malignancies, today announced that the new indication - adult patients with chronic-phase chronic myeloid leukemia (CML-CP) resistant and/or intolerant of first-and second-generation tyrosine kinase inhibitors (TKIs) - of its novel drug, olverembatinib (HQP1351), has been included into the China 2024 National Reimbursement Drug List (NRDL), effective January 1, 2025. This indication was added to the NRDL through the simple contract renewal process. The previously included indication of adult patients with CML-CP or accelerated-phase CML (CML-AP) harboring the T315I mutation will maintain its reimbursable status on the NRDL. Olverembatinib is a novel drug developed by Ascentage Pharma with support from the National Major New Drug Development Program in China and the first third-generation BCR-ABL inhibitor approved by the China National Medical Products Administration (NMPA). As a novel drug, olverembatinib can effectively target BCR-ABL and a spectrum of BCR-ABL mutants, including the T315I mutation. In November 2021, olverembatinib received its first approval in China, thus became the first therapy approved for the treatment of T315I mutant CML in the country. In November 2023, olverembatinib was approved for the treatment of adult patients with CML-CP resistant and/or intolerant of first-and second-generation TKIs. Olverembatinib is being jointly commercialized in China by Ascentage Pharma and Innovent Biologics. CML is a hematologic malignancy of the white blood cells. The introduction of BCR-ABL TKIs have significantly improved the management of CML. However, TKI resistance is still a global challenge for CML treatment. 20%-40% of patients fail to achieve desired treatment outcome due to resistance or intolerance to TKIs1-3, thus leading to disease progression or even death. The successful renewal and the inclusion of additional indication of olverembatinib in the NRDL is expected to greatly improve the drug's accessibility, bringing benefit to more and a broader population of patients with CML in China. "We are glad that the new indication of olverembatinib has been included into the NRDL through the simple contract renewal process," said Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma. "This decision reaffirms the importance of olverembatinib as an innovative drug that has the potential to fulfill the urgent unmet needs and treatment gaps in CML. With its new indication included into the NRDL at the third anniversary of the initial approval in China, olverembatinib is positioned to bring renewed hope to more patients with CML, thereby helping countless families and communities. Moving forward, we will work actively to ensure the rapid rollout of the expanded insurance coverage. We are confident these efforts will make olverembatinib more accessible and affordable, ultimately allowing more patients and their families to benefit from this novel therapeutic as soon as possible." References O'Brien SG, Guilhot F, Larson R, et al. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. Engl J Med. 2003 Mar 13;348(11):994-1004. Jabbour E, Kantarjian H. Chronic myeloid leukemia: 2014 update on diagnosis, monitoring, and management. Am J Hematol. 2014 May;89(5):547-56. Larson R, Hochhaus A, Hughes T, et al. Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up. Leukemia. 2012 Oct;26(10):2197-203. * Olverembatinib is an investigational drug that has not been approved for any indication outside China. About Olverembatinib Developed by Ascentage Pharma, the novel drug olverembatinib is an orally-available third-generation tyrosine kinase inhibitor (TKI), and the first China-approved third-generation BCR-ABL inhibitor that can effectively target BCR-ABL and a spectrum of BCR-ABL mutants, including the T315I mutation. Olverembatinib, developed with support from the National Major New Drug Development Program in China, has also been granted Priority Review designations and Breakthrough Therapy designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). At present, olverembatinib has been approved in China for the treatment of adult patients with TKI-resistant chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation; and adult patients with CML-CP resistant and/or intolerant of first-and second-generation TKIs. In addition to CML, olverembatinib has also shown potential clinical benefits to patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). A global registrational Phase III study of olverembatinib in newly diagnosed patients with Ph+ ALL is currently underway, potentially paving the way for olverembatinib become the first China-approved TKI for the treatment of patients with Ph+ ALL in the first-line setting. In the area of solid tumors, olverembatinib is being evaluated in a global registrational Phase III study for the treatment of succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST) and has already been granted a Breakthrough Therapy designation by the China CDE. As a novel drug, olverembatinib has received widespread interest from the global hematology community. The clinical results of olverembatinib have been selected for oral presentations at the American Society of Hematology (ASH) Annual Meetings for seven consecutive years. To date, olverembatinib has been granted four Orphan Drug Designations and a Fast Track Designation by the US Food and Drug Administration (FDA), and an Orphan Designation by the EMA of the EU. In February 2024, olverembatinib was cleared by the US FDA to enter a global registrational Phase III study. In July 2021, Ascentage Pharma (6855.HK) and Innovent Biologics (1801.HK) reached the agreement regarding the joint development and commercialization of olverembatinib in China. In June 2024, Ascentage Pharma and Takeda, a multinational pharmaceutical company, entered into an Exclusive Option Agreement for olverembatinib. If exercised, the Option would allow Takeda to license global rights to develop and commercialize olverembatinib in all territories outside of, among others, the mainland China, Hong Kong China, Macau China, and Taiwan China. About Ascentage Pharma Ascentage Pharma (6855.HK) is a global, integrated biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet medical needs primarily in malignancies. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK. The company has built a rich pipeline of innovative drug candidates that includes novel, highly potent Bcl-2 and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation TKIs. Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company has conducted more than 40 clinical trials in the US, Australia, Europe, and China, including 13 registrational studies (completed/ ongoing/planned). Olverembatinib, the company's first lead asset developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company's first approved product in China, has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into the China National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted Orphan Drug Designations (ODDs) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU. To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company's investigational drug candidates. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies such as Takeda, AstraZeneca, Merck, Pfizer and Innovent; and research and development relationships with leading research institutions such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. The company has built a talented team with a wealth of global experience in the discovery and development of innovative drugs and fully functional commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients. Forward-Looking Statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions and expectations or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions and expectations may alter in light of future development. SOURCE Ascentage Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SAN FRANCISCO and SUZHOU, China, Nov. 27, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that the updated 2024 National Reimbursement Drug List (NRDL) now includes SINTBILO® (tafolecimab injection, an anti-PCSK9 monoclonal antibody) for the first time, along with a new indication of olverembatinib (a BCR-ABL inhibitor) on the list. The updated NRDL will be officially effective from January 1, 2025. In the updated NRDL, SINTBILO® is newly listed for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial types) and mixed dyslipidemia. SINTBILO® (tafolecimab injection) is Innovent's first entry into the cardiovascular field, offering multiple dosing options: 150mg Q2W, 450mg Q4W, and 600mg Q6W. These regimens significantly reduce low-density lipoprotein cholesterol (LDL-C) levels by nearly 70% and lower lipoprotein a [Lp(a)] by nearly 50%. As the first domestic PCSK9 inhibitor in the NRDL, SINTBILO® provides an important new treatment option for cholesterol management in China, improving quality of life for a broad population of patients with hypercholesterolemia. As for olverembatinib, its first indication was renewed and the new indication was also included in the updated NRDL through the simple contract renewal process. The NRDL coverage of olverembatinib includes: for the treatment of adult patients with chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation; and for the treatment of adult patients with CML-CP resistant and/or intolerant of first-and second-generation tyrosine kinase inhibitors (TKIs). Olverembatinib is the first third-generation BCR-ABL inhibitor approved by China's National Medical Products Administration (NMPA). Innovent and Ascentage Pharma are mutually committed to the commercialization of olverembatinib in the Chinese market. Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "We are pleased with the inclusion of SINTBILO® in the NRDL, which will significantly increase the accessibility and affordability of this innovative therapy and marks a significant achievement for both Innovent and patients with hypercholesterolemia. We are also encouraged by the inclusion of the new indication of olverembatinib in the NRDL, which will benefit a broader range of CML patients. As a company with the mission of 'empowering patients worldwide with affordable, high-quality biopharmaceuticals', Innovent continues to invest in pioneering treatments across key areas—oncology, cardiovascular and metabolic (CVM), autoimmune and ophthalmology—where there is substantial societal need. We look forward to building on our patient-centered approach, leveraging our product strengths, and further improving drug affordability and accessibility, so that high-quality drugs can benefit more patients and their families as soon as possible. We are proud to contribute to the better care of our patients." About SINTBILO® (Tafolecimab Injection) SINTBILO® (tafolecimab injection), developed independently by Innovent, is a fully human lgG2 monoclonal antibody that can specifically bind to PCSK9, reducing LDL-C levels by inhibiting PCSK9-mediated low-density lipoprotein receptor (LDLR) endocytosis and enhancing LDL-C clearance. SINTBILO® is indicated and included in the NRDL for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial types) and mixed dyslipidemia. About Olverembatinib Olverembatinib is an orally-available third-generation tyrosine kinase inhibitor (TKI), and the first China-approved third-generation BCR-ABL inhibitor that can effectively target BCR-ABL and a spectrum of BCR-ABL mutants, including the T315I mutation. At present, olverembatinib has been approved and included in the NRDL in China for the treatment of adult patients with chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation; and adult patients with CML-CP resistant and/or intolerant of first-and second-generation TKIs. In July 2021, Innovent and Ascentage Pharma (6855.HK) reached the agreement regarding the joint development and commercialization of olverembatinib in China. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 5 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED